Nonarteritic Anterior Ischemic Optic Neuropathy
Conditions
Keywords
nonarteritic anterior ischemic optic neuropathy, platelet-rich plasma, subtenon injection
Brief summary
This prospective randomized clinical study aims to evaluate the efficacy and safety of autologous platelet-rich plasma (PRP) injection in patients with acute non-arteritic anterior ischemic optic neuropathy (NAION). Eligible patients are randomly assigned to receive posterior subtenon PRP injections or to an observation-only control group. The PRP group receives injections at baseline and during follow-up. Comprehensive ophthalmologic evaluations, including best-corrected visual acuity, visual field testing, and retinal nerve fiber layer thickness measurements, are performed at baseline and scheduled follow-up visits. The primary outcomes include changes in visual function and structural optic nerve parameters, as well as the incidence of treatment-related adverse events.
Detailed description
This prospective randomized clinical study is designed to evaluate the efficacy and safety of posterior subtenon autologous platelet-rich plasma (PRP) injection in patients diagnosed with acute non-arteritic anterior ischemic optic neuropathy (NAION). Patients meeting the inclusion criteria are enrolled and randomly assigned, using computer-assisted randomization, to either the PRP treatment group or an observation-only control group. Patients in the PRP group receive posterior subtenon injections of autologous PRP at baseline and during scheduled follow-up visits. The control group is managed with observation alone and receives no interventional treatment. All participants undergo comprehensive ophthalmologic examinations at baseline and at predefined follow-up visits, including assessments of best-corrected visual acuity, visual field testing, and retinal nerve fiber layer thickness measurements obtained by optical coherence tomography. Patients are followed longitudinally to assess changes in functional and structural optic nerve parameters, as well as to monitor for any ocular or systemic adverse events related to the intervention. Safety evaluations are performed at each follow-up visit throughout the study period.
Interventions
BIOLOGICALAutologous Platelet-Rich Plasma (PRP)
Autologous platelet-rich plasma is prepared from the participant's own blood and administered via posterior subtenon injection at scheduled visits.
Sponsors
Uludag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible participants are randomly assigned to one of two parallel groups. One group receives posterior subtenon autologous platelet-rich plasma injections, while the control group is managed with observation alone. Participants remain in their assigned groups throughout the study period.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acute non-arteritic anterior ischemic optic neuropathy (NAION) based on clinical history and ophthalmologic examination Acute, painless vision loss and/or visual field defect Symptom onset within 14 days prior to enrollment Age 40 years or older Ability to cooperate with best-corrected visual acuity and visual field examinations Willingness and ability to complete all follow-up visits (weeks 1, 3, 6, 8, and 16) Provision of written informed consent
Exclusion criteria
* Arteritic anterior ischemic optic neuropathy Posterior ischemic optic neuropathy Age under 40 years Presence of concomitant ocular diseases that could affect visual outcomes (e.g., glaucoma, diabetic macular edema, retinal dystrophy) Presence of neurological diseases that may affect the optic nerve (e.g., demyelinating disease, intracranial or intraorbital mass) Inability to cooperate with visual acuity or visual field testing Presence of systemic hematological disorders that could interfere with platelet-rich plasma preparation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) | Baseline (Week 0) to Week 16 | Change in best-corrected visual acuity from baseline (week 0) to week 16, measured in logarithm of the minimum angle of resolution (logMAR) units using standard visual acuity charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Field Mean Deviation (MD) and Visual Field Index (VFI) | Baseline (Week 0) to Week 16 | Change in visual field mean deviation (MD) and visual field index (VFI) measured by automated perimetry (Humphrey Field Analyzer 30-2) from baseline to week 16. |
| Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness | Baseline (Week 0) to Week 16 | Change in global and sectoral peripapillary retinal nerve fiber layer thickness measured by spectral-domain optical coherence tomography (OCT) from baseline to week 16. |
Countries
Turkey (Türkiye)
Outcome results
None listed